To Evaluate the Efficacy of AL-38583 in the Reduction of Tear Eosinophil Count Following Conjunctival Allergen Challenge

Phase 2

Withdrawn

• Conditions: Allergic Conjunctivitis
• Interventions: Drug: AL38583 Ophthalmic Solution; Drug: Maxidex; Drug: Vehicle

• Registration Number: NCT00881673
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of the study is to determine whether Al38583 Ophthalmic Solution is safe and effective in reducing tear eosinophil levels at 5-8 hours after Conjunctival Allergen Challenge (CAC).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-14
• Study First Submitted QC: 2009-04-14
• Study First Posted: 2009-04-15
• Study Start: 2009-05
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2012-02
• Last Update Submitted: 2012-03-03
• Last Update Posted: 2012-03-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Have a positive bilateral CAC reaction (>2 itching and > conjunctival redness) to cat hair, cat dander, dust mites, cockroaches and/or dog dander within 10 minutes of instillation of the last titration of allergen at Visit 1

Exclusion Criteria

• Have a known allergy to the study medication(s) or their components (ex., dexamethasone, benzalkonium chloride)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AL38583 Ophthalmic Solution	-
2	Maxidex	-
3	Vehicle	-

Primary Outcome Measures

Name	Time	Method
The primary efficacy variable is mean change in tear eosinophil level at Visit 7 post-CAC from Visit 2 post-CAC.	15 days

Secondary Outcome Measures

Name	Time	Method
Mean change in relative ratio of tear eosinophil and neutrophils at Visit 7 post-CAC from Visit 2 post-CAC	15 days